A Study of ASP8302 in Participants With Underactive Bladder

Exclusion Criteria

• •At visit 1:
• •Related to lower urinary tract:
• •Subject has significant BOO:
• •* Subject has clinically significant urethral stricture (e.g., requiring surgery).
• •* Female subject has uterus prolapse ≥ Grade 2 Shaw's system (up to or outside the introitus), moderate or severe cystocele (reaches or protrudes outside the introitus).
• •* Male subject has a bladder outlet obstruction index (BOOI) ≥ 40 cm H2O on pressure flow study (PFS) (either performed on screening or within 12 months of the screening visit), or -if PFS is not available-a prostate volume (PV) of \> 40 mL (Europe) \> 30 mL (Japan) on ultrasound (either performed on screening or within 6 months of the screening visit). Note: if PFS is available and PV is above the cut-off level, the subject is not to be excluded if bladder outlet obstruction index (BOOI) is \< 40.
• •* Other condition that constitutes significant BOO.
• •Subject is known to have urgency urinary incontinence that is clinically significant.
• •Subject is known to have 1 or more bladder diverticuli that is/are clinically significant.
• •Subject is known to have vesico-ureteral/renal reflux that is clinically significant.
• •Subject has a urinary catheter in situ (including suprapubic catheters).
• •Subject is known to have 1 of the following conditions as a primary cause for subject's UAB, or a condition that could potentially influence treatment outcome:
• •* Neurological lesion or condition, including cerebrovascular accident, spinal lumbar disc hernia, spinal cord injury, multiple sclerosis, Parkinson's disease, Guillain-Barré syndrome, pudendal, hypogastric or pelvic nerve lesion. Diabetes mellitus is allowed if controlled with or without medical treatment (e.g., HbA1C \< 7%).
• •* Increased pelvic floor muscle activity during voiding (e.g., dyssynergic striated sphincteric activity/striated sphincteric activity during voiding, Fowler syndrome and pelvic floor muscle spasm).
• •* Previous bladder surgery (e.g., bladder augmentation or reduction surgery, latissimus dorsi detrusor myoplasty). Prior Benign Prostatic Obstruction surgery or pelvic organ prolapse surgery is allowed if performed more than 6 months prior to screening.
• •* Previous implant surgery for incontinence still in situ (e.g., tape, sling or artificial sphincter)
• •* Significant active urological pain syndrome.
• •* Previous pelvic radiation therapy.
• •Dependence on use of a manual assistance method intended to improve bladder emptying (e.g., Credé's maneuver or suprapubic tapping).
• •Related to (previous or current) treatment and/or study drug:
• •Subject is receiving 1 or more of the following non-medication therapies:
• •* Electrostimulation therapy, e.g., neurostimulation/modulation or sacral nerve stimulation in the past 3 months.
• •* Intravesical or injection based treatment (e.g., botulinum toxin injections in urethra or bladder in the past 12 months).
• •* An ongoing bladder training program and/or pelvic floor muscle exercises, which started within 6 weeks prior to visit 1.
• •* Muscle-derived stem cell injection in the bladder or urethra or bladder transplantation at any time prior to screening.
• •Subject is using prohibited medications or subject is using restricted medications under conditions different to those specified in the concomitant medication section.
• •Subject has a known or suspected hypersensitivity to ASP8302 or any of the inactive ingredients.
• •Related to concomitant conditions:
• •Subject is known to have inflammatory bowel disease or clinically significant diarrhea.
• •Subject is known to be immunocompromised due to conditions such as human immunodeficiency virus/acquired immune deficiency syndrome or hepatitis C.
• •Subject has been diagnosed with clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to visit 1, such as myocardial infarction, uncontrolled angina/coronary artery disease, significant ventricular arrhythmias and heart failure (New York Heart Association class III/IV).
• •Subject has been diagnosed with clinically significant asthma, chronic bronchitis and/or chronic obstructive pulmonary disease.
• •Subject is known to have a mean Fridericia corrected QT interval (QTcF) \> 430 ms for males or \> 450 ms for females, a pre-existing long QT syndrome or hypokalemia.
• •Subject has a clinically significant abnormal 12-lead ECG.
• •Subject has severe overactive bladder (OAB), i.e., experienced 3 or more episodes of urgency (Patient Perception of Intensity of Urgency Scale (PPIUS) grade 3 or 4), during the 3-day micturition diary period prior to visit 2.